An Observational Study Investigating the Safety and Effectiveness of Repaglinide in Chinese Patients

Novo Nordisk A/S2,033 enrolled

Overview

This study is conducted in Asia. The aim of this observational study is, under normal clinical practice conditions, to investigate the clinical safety and effectiveness in Chinese patients with type 2 diabetes who have never received anti-diabetic treatment before.

Study Type

OBSERVATIONAL

Enrollment

2,033

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

repaglinideDRUG

Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HbA1c more than 6.5%, no anti-diabetes treatment accepted before entering the study Exclusion Criteria: * Subjects who received any anti-diabetic treatment previously * Known or suspected allergy to trial product(s) or related products. * Subjects who previously enrolled in this study. * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.

Locations (1)

Unnamed facility

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Number of serious adverse drug reactions (SADRs) including major hypoglycaemic (low blood sugar) events

Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)

Secondary Outcomes

Number of minor hypoglycaemic (low blood sugar) episodes

Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)

Number of adverse drug reactions (ADRs)

Time frame: at Visit 2(8 weeks) and visit 3(16 weeks)

Change in HbA1c

Time frame: after 16 weeks of treatment

Change in fasting blood glucose (FBG)

Time frame: after 8 and 16 weeks of treatment

Change in postprandial blood glucose (PBG)

Time frame: after 8 and 16 weeks treatment

Data from ClinicalTrials.gov

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